DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
Applicant’s amendments filed on 01/30/2026 have been fully considered. Claims 1-15 are pending in this application. Claims 1-4 and 6-9 are amended. Claims 11-15 are newly added.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 and 5 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. More specifically, the claim amendments regarding “wherein at least the distal tip of the catheter is flexible” further narrows the scope of the claimed invention.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 6-11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 6, 8, 11, 13, and 15 of U.S. Patent No. 12,478,390. Although the claims at issue are not identical, they are not patentably distinct from each other because the claim of the patented case recite the claim limitations required in the current application. The table below shows the mapping of the overlapping claim between the current application and the patented case.
Instant Claims
Patented claims of Patent No. 12,478,390 B2
6
6
7
15
8
13
9
11
10
8
11
6
Claim Objections
Claim 10 is objected to because of the following informalities: lines 4-5: “a first intensity level” should read “the first intensity level” at line 4 and “a second intensity level” should read “the second intensity level” at line 5. Appropriate correction is required.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 5-9 and 11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bagaoisan et al. (Patent No. US 6,152,909 A).
Regarding claim 5, Bagaoisan discloses a system for facilitating aspiration of a thrombus within vasculature (aspiration system for aspirating thrombi; Figure 17; Abstract; Column 14, lines 3-22), the system comprising: a catheter (aspiration catheter 150; Figure 17; Column 2, lines 50-67, Column 3, lines 8-21, and Column 14, lines 3-22) comprising an open, atraumatic distal tip (“The distal tip 22… is preferably soft to prevent damage to the patient's vasculature.”; Column 8, lines 26-29; Figure 17), wherein at least the distal tip of the catheter is flexible (“The distal tip on the catheter is formed of a more flexible material than that used to form the rest of the catheter shaft.”; Column 3, lines 8-20; Figure 17); and a suction device configured to facilitate aspiration (source of aspiration/syringe 160, and tubing 154; Figure 17; Column 14, lines 23-38), the suction device comprising: a vacuum source (source of aspiration/syringe 160; Figure 17; Column 14, lines 23-38); and suction tubing (tubing 154; Figure 17; Column 14, lines 3-38), wherein the suction device is configured to generate at least one cyclical suction output (Bagaoisan; valve 158 switched between close to open and open to close positions to change the suction pressure at the distal tip of the catheter 150, creating a cyclical suction output; Column 14, lines 28-38; Figure 17).
Regarding claim 6, Bagaoisan discloses the system of claim 5. Bagaoisan further discloses wherein the vacuum source is a single vacuum source that, when in use, is in fluid communication with a lumen of the catheter and is connected through a tubing directly to a proximal end of the catheter or indirectly through a valve to (i) the proximal end of the catheter (vacuum source 160 is connected to valve 158, to tubing 154, and to proximal end of catheter 150; Figure 17; Column 14, lines 3-38) or (ii) the proximal end of the catheter and a second catheter positioned within the catheter.
Regarding claim 7, Bagaoisan discloses the system of claim 5. Bagaoisan further discloses wherein the at least one cyclical suction output comprises at least one repetitive cyclical suction output (“The stopcock 158 may be opened and closed repeatedly to deliver the aspiration pressure in a pulsed manner if desired.”, meaning that the pulsing of suction pressure is repeating cyclical suction output by closing and opening the valve repetitively; Figure 17; Column 14, lines 28-38).
Regarding claim 8, Bagaoisan discloses the system of claim 5. Bagaoisan further discloses wherein the catheter comprises a connector, a valve, a microcatheter, a distal access microcatheter, a guide catheter, a shuttle catheter, a venous catheter, an aspiration catheter, a delivery catheter, a balloon guide catheter, a ventriculostomy catheter, an endoscope, a laparoscope, or combinations thereof (aspiration catheter 150 has a valve 158 and adaptor 153/connecter; Figure 17; Column 14, lines 3-22).
Regarding claim 9, Bagaoisan discloses the system of claim 5. Bagaoisan further discloses wherein the at least one cyclical suction output is configured to be generated or changed at a location between the vacuum source and the distal tip of the catheter (negative pressure is generated/changed at the valve 158 between the source 158 and distal tip of catheter 150; Figure 17; Column 14, lines 3-22).
Regarding claim 11, Bagaoisan discloses the system of claim 5. Bagaoisan further discloses wherein the suction device is a negative suction device (Column 14, line 3-38).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-4, 10, and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Bagaoisan et al. (Patent No. US 6,152,909 A) in view of Zadno-Azizi (Publication No. US 2002/0052638 A1).
Regarding claim 1, Bagaoisan teaches a system for facilitating aspiration of a thrombus within vasculature (aspiration system for suctioning thrombi; Figure 17; Abstract; Column 14, lines 3-22), the system comprising: a catheter (aspiration catheter 150; Figure 17; Column 2, lines 50-67, Column 3, lines 8-21, and Column 14, lines 3-22) comprising an open, atraumatic distal tip (“The distal tip 22… is preferably soft to prevent damage to the patient's vasculature.”; Column 8, lines 26-29; Figure 17), wherein at least the distal tip of the catheter is flexible (“The distal tip on the catheter is formed of a more flexible material than that used to form the rest of the catheter shaft.”; Column 3, lines 8-20; Figure 17); and a vacuum source configured to generate a suction output (source of aspiration/syringe 160 produces vacuum; Figure 17; Column 14, lines 23-38), wherein, when in use, the vacuum source is in fluid communication with a lumen of the flexible catheter (vacuum source 160 is in fluid communication with a lumen of catheter 150; Figure 17; Column 14, lines 23-38) and is connected through a tubing directly to a proximal end of the catheter or indirectly through a valve to (i) the proximal end of the catheter (vacuum source 160 is connected to valve 158, to tubing 154, and to proximal end of catheter 150; Figure 17; Column 14, lines 3-38) or (ii) the proximal end of the catheter and a second catheter positioned within the catheter, wherein the valve is configured to control at least one of a change in suction pressure or a flow of the suction output (valve 158 changes the suction pressure between an open and close position; Figure 17; Column 14, lines 3-38), wherein the change in suction pressure comprises: a first intensity level having a first suction pressure (a first intensity level having a first suction pressure is when stopcock is opened and vacuum is delivered to the catheter; Column 14, lines 28-38); or a second intensity level having a second suction pressure of 0 to -350 mm Hg (a second intensity level having a second suction pressure at 0 mm Hg when the stopcock is in the closed position; Column 14, lines 28-38). The term “atraumatic” is interpreted to be designed to minimize tissue damage or not causing injury or trauma, as defined by Merriam-Webster Dictionary (see attached PTO-892). Bagaoisan does not teach wherein the change in suction pressure comprises: the first suction pressure less negative than -760 mm Hg.
However, Zadno-Azizi teaches comprising a suction pressure that is approximately 3-30 inches of mercury, or about 76.2 mmHg to 762 mmHg (Paragraph 0200; Figure 41).
Bagaoisan and Zadno-Azizi are both considered to be analogous to the claimed invention because they are in the same field of emboli aspiration. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Bagaoisan to incorporate the teachings of Zadno-Azizi and have the negative pressure range of Zadno-Azizi as the first intensity of the first pressure produced by the vacuum source of Bagaoisan. This allows for the aspiration of larger emboli into the system (Zadno-Azizi; Paragraph 0200).
Regarding claim 2, Bagaoisan in view of Zadno-Azizi teaches the system of claim 1. The combination of Bagaoisan in view of Zadno-Azizi further teaches wherein the vacuum source comprises one of an automated suction device or a vacuum pump (Bagaoisan; mechanical pump can replace syringe as a vacuum source; Column 16, lines 4-16), and wherein the vacuum source is a single vacuum source (Bagaoisan; vacuum source 160 is a single vacuum source; Figure 17).
Regarding claim 3, Bagaoisan in view of Zadno-Azizi teaches the system of claim 1. The combination of Bagaoisan in view of Zadno-Azizi further teaches wherein the vacuum source comprises at least one of a manual suction device or a syringe (Bagaoisan; source of aspiration/syringe 160; Figure 17; Column 14, lines 23-38).
Regarding claim 4, Bagaoisan in view of Zadno-Azizi teaches the system of claim 1. The combination of Bagaoisan in view of Zadno-Azizi further teaches wherein the valve is configured to open and close to cyclically change the suction pressure at the distal tip of the catheter or the second catheter positioned within the catheter (Bagaoisan; valve 158 switched between close to open and open to close positions to change the suction pressure at the distal tip of the catheter 150, creating a cyclical suction output; Column 14, lines 28-38; Figure 17).
Regarding claim 10, Bagaoisan discloses the system of claim 7. Bagaoism further teaches wherein the at least one repetitive cyclical suction output comprises at least two different intensity levels (“The stopcock 158 may be opened and closed repeatedly to deliver the aspiration pressure in a pulsed manner if desired.”, meaning that the pulsing of suction pressure is repeating cyclical suction output between 0 mm Hg/second intensity level to a first intensity level by closing and opening the valve repetitively; Figure 17; Column 14, lines 28-38), with a first intensity level having a first suction pressure (a first intensity level having a first suction pressure is when stopcock is opened and vacuum is delivered to the catheter; Column 14, lines 28-38) and a second intensity level having a second suction pressure of 0 to -350 mm Hg (a second intensity level having a second suction pressure at 0 mm Hg when the stopcock is in the closed position; Column 14, lines 28-38), wherein a first intensity level of the at least two different intensity levels has a first duration, and wherein a second intensity level of the at least two different intensity levels has a second duration (obvious that switching between the first intensity level and the second intensity levels would have a first and second duration).
Bagaoisan does not teach the first suction pressure less negative than -760 mm Hg.
However, Zadno-Azizi teaches comprising a suction pressure that is approximately 3-30 inches of mercury, or about 76.2 mmHg to 762 mmHg (Paragraph 0200; Figure 41).
Bagaoisan and Zadno-Azizi are both considered to be analogous to the claimed invention because they are in the same field of emboli aspiration. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Bagaoisan to incorporate the teachings of Zadno-Azizi and have the negative pressure range of Zadno-Azizi as the first intensity of the first pressure produced by the vacuum source of Bagaoisan. This allows for the aspiration of larger emboli into the system (Zadno-Azizi; Paragraph 0200).
Regarding claim 12, Bagaoisan in view of Zadno-Azizi teaches the system of claim 1. The combination of Bagaoisan in view of Zadno-Azizi further teaches wherein the suction output is configured to be generated or changed at a location between the vacuum source and the distal tip of the catheter or the second catheter (negative pressure is generated/changed at the valve 158 between the source 158 and distal tip of catheter 150; Figure 17; Column 14, lines 3-22).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE-PH M PHAM whose telephone number is (571)272-0468. The examiner can normally be reached Mon-Fri, 8AM to 5PM ET.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rebecca Eisenberg can be reached at (571) 270-5879. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/KATHERINE-PH MINH PHAM/Examiner, Art Unit 3781
/KAI H WENG/Primary Examiner, Art Unit 3781
Prosecution Insights